Sleep and Immune Checkpoint Inhibitors

Lung Cancer Clinical Trial

Official title: Sleep Disturbance and Its Association With Fatigue, Depressive Symptoms, and Clinical Response to Immune Checkpoint Inhibitors (ICI) in Lung Cancer Patients

Status Recruiting

Clinical Trial Summary

Sleep disturbances are prevalent in cancer patients and linked to levels of fatigue and depressive symptoms with a major impact on quality of life. A growing body of evidence links sleep disturbances with various health outcomes, including increased risk of depression, cancer, and overall mortality. Inflammation is suggested to be an underlying mechanism both driving and maintaining the symptom cluster of sleep disturbance, fatigue and depressive symptoms, as well as being bi-directionally linked to sleep. The main purpose of the present study is to investigate the prevalence of sleep disturbance and its association with psychological and physical symptoms as well as the clinical response to ICI in non-small-cell lung cancer patients (NSCLC), with a secondary aim of exploring the role of inflammation.

Clinical Trial Description

A total of 240 cancer patients diagnosed with advanced NSCLC, referred to treatment with ICI will be enrolled in this prospective observational study. Patients will be assessed prior to initiation of treatment (baseline) and every third subsequent week, corresponding to each treatment cycle over a period of 18 weeks. Assessments will include questionnaires, sleep diaries, actigraphy, and blood and saliva samples to examine sleep, fatigue, psychological and physical symptoms, the sleep-wake-cycle, inflammation, and cortisol. Additionally, the patients will be asked to complete a reduced questionnaire every week within the 18 weeks period, to address weekly fluctuations in sleep quality, fatigue, and mood. Treatment response is assessed after 9 and 18 weeks.

Aims:

1. To explore possible associations between sleep and the clinical response to treatment with ICI.

2. To investigate the prevalence of sleep disturbance in patients with NSCLC during treatment with ICI.

3. To prospectively assess changes in sleep parameters over the course of treatment.

4. To examine associations between sleep parameters and fatigue, depression, anxiety, and inflammation.

5. To explore possible associations between sleep, fatigue, depression, inflammatory responses and the clinical response to treatment with ICIs.

Hypotheses:

Patients with high levels of sleep disturbance (insomnia severity) will experience 1) poorer clinical response to ICI, 2) more depressive symptoms, 3) higher levels of fatigue, 4) poorer overall health-related quality of life (HRQoL), 5) higher levels of inflammation. ;

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

• NCT number: NCT04070651
• Study type: Observational
• Source: Aarhus University Hospital
• Contact: Louise Stroem, MSc
• Phone: 0045 8716 5076
• Email: louisestroem@psy.au.dk
• Status: Recruiting
• Start date: August 5, 2019
• Completion date: November 2022